Abstract 5697
Background
We aimed to investigate the association between blood cell count-based immuno-inflammatory parameters, clinico-pathological characteristics and clinical outcomes in patients (pts) with RAS wt, metastatic colorectal cancer (mCRC) randomized to panitumumab (pani) plus FOLFOX4 induction followed by maintenance with pani +/- 5FU/LV in the phase 2 Valentino study.
Methods
Pts in the intention-to-treat population (n = 229) were screened for the availability of pre-treatment complete blood cell count. We focused on neutrophil-to-lymphocyte ratio (NLR), absolute monocyte count (AMC) and platelet count (PC). NLR and AMC were defined high if ≥ 4 and 900/mcl, respectively, based on literature data. PC was defined high if > of the median value of the study population. The Kaplan-Meier method and Cox proportional hazards regression model were used for survival analyses.
Results
A total of 215 pts were included. NLR and AMC were significantly associated with ECOG PS. AMC and PC were associated with the presence of synchronous metastases and primary tumor resection. After a median follow-up of 26.7 months, high NLR was associated with worse progression-free survival [PFS] (HR 1.51, p = 0.015) and overall survival [OS] (HR 2.18, p < 0.001), as well as high AMC (HR for PFS 1.85, p = 0.003; HR for OS 2.49, p < 0.001) and high PC (HR for PFS 1.65, p = 0.001; HR for OS 1.85, p = 0.003). In the multivariable models, only PC confirmed its independent association with both clinical outcomes (HR for PFS 1.71, p < 0.001; HR for OS 1.70, p = 0.01), while AMC was only independently associated with PFS (HR 2.44, p = 0.03) and NLR did not demonstrate any significant association. The PFS benefit of adding 5-FU/LV to pani in the maintenance setting was independent from NLR and AMC (interaction p = 0.15 and p = 0.48, respectively), but was retained only in the subgroup with low PC (interaction p = 0.04). No significantly association with response or disease control was observed.
Conclusions
In pts with RAS wt, mCRC randomized in the Valentino study, baseline PC showed and independent association with OS and PFS and baseline AMC was independently associated with PFS. Pts with high PC did not derive any PFS benefit from the addiction of 5-FU/LV to pani in the maintenance setting.
Clinical trial identification
NCT02476045.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Amgen.
Disclosure
S. Lonardi: Honoraria (self): Roche; Honoraria (self): Amgen; Honoraria (self): Bayer; Honoraria (self): Merck-Serono; Honoraria (self): Servier; Honoraria (self): Bristol-Myers Squibb. L. Rimassa: Honoraria (self): AstraZeneca; Honoraria (self): AbbVie; Honoraria (self): Lilly; Honoraria (self): Bayer; Honoraria (self): Sirtex Medical; Honoraria (self): Italfarmaco; Honoraria (self): Sanofi; Honoraria (self): ArQule; Honoraria (self): Baxter; Honoraria (self): Ipsen; Honoraria (self): Exelixis; Honoraria (self): Amgen; Honoraria (self): Incyte; Honoraria (self): Celgene. A. Zaniboni: Honoraria (self): Sanofi; Honoraria (self): Amgen; Honoraria (self): Bayer; Honoraria (self): Merck-Serono; Honoraria (self): Roche. A. Sartore-Bianchi: Honoraria (self): Sanofi; Honoraria (self): Amgen; Honoraria (self): Bayer; Honoraria (self): Merck-Serono; Honoraria (self): Roche. M. Di Bartolomeo: Honoraria (self): Amgen; Honoraria (self): Roche; Honoraria (self): Lilly; Honoraria (self): Servier; Honoraria (self): Incyte; Honoraria (self): Celgene. F.G.M. De Braud: Honoraria (self): Amgen; Honoraria (self): Roche; Honoraria (self): Novartis. F. Pietrantonio: Honoraria (self): Sanofi; Honoraria (self): Amgen; Honoraria (self): Bayer; Honoraria (self): Merck-Serono; Honoraria (self): Roche; Honoraria (self): Servier. All other authors have declared no conflicts of interest.
Resources from the same session
5773 - A prospective study of diffusion-weighted magnetic resonance imaging for predicting outcome following chemoradiotherapy, in squamous cell carcinomas of the anus.
Presenter: Rebecca Muirhead
Session: Poster Display session 2
Resources:
Abstract
4581 - Timing to achieve complete response (CR) after definitive chemoradiotherapy (ChRT) in patients with squamous cell carcinoma of the anal (SCCAC) with and without HIV infection: a multicenter retrospective study
Presenter: Marcos Camandaroba
Session: Poster Display session 2
Resources:
Abstract
1712 - Planned organ preservation for T2 T3 M0 rectal adenocarcinoma. A possible option using chemoradiotherapy (CRT) and Contact X-ray Brachytherapy (CXB). A French multicenter study.
Presenter: Jean-Pierre Gérard
Session: Poster Display session 2
Resources:
Abstract
4639 - A Phase 1b Study of E7046 (AN0025) in Combination With Radiotherapy/Chemoradiotherapy (RT/CRT) in Preoperative Treatment of Rectal Cancer
Presenter: Lucjan Wyrwicz
Session: Poster Display session 2
Resources:
Abstract
2310 - Upfront radical surgery with total mesorectal excision (TME) versus preoperative chemoradiotherapy followed by TME in clinical stage II/III patients with rectal cancer: a propensity score analysis
Presenter: Ahrong Ham
Session: Poster Display session 2
Resources:
Abstract
2747 - Neoadjuvant chemoradiotherapy with/without lateral lymph node dissection for low rectal cancer: Which patients can benefit?
Presenter: Daisuke Nishizaki
Session: Poster Display session 2
Resources:
Abstract
2877 - The impact of completeness of chemotherapy on the efficacy of irinotecan in the preoperative chemoradiotherapy of locally advanced rectal cancer.
Presenter: Jingwen Wang
Session: Poster Display session 2
Resources:
Abstract
3050 - Feasibility of robot-assisted surgery in elderly patients with rectal cancer
Presenter: Wei-Chih Su
Session: Poster Display session 2
Resources:
Abstract
4109 - Feasibility of chemoradiotherapy in rectal cancer patients with peritumoral abscesses and fistulas: a case-control non-inferiority trial
Presenter: Valerii Ivanov
Session: Poster Display session 2
Resources:
Abstract
4813 - Differential of the nutritional index before and after neoadjuvant chemoradiotherapy as a prognostic factor of recurrence in patients with locally advanced adenocarcinoma of the rectum
Presenter: Leslie Navia-Ortuño
Session: Poster Display session 2
Resources:
Abstract